(602 days)
A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove together. Please note that the following drugs have extremely low permeation times: 3.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.
Gammex® Pl Plus Glove-in-Glove™ System tested for use with Chemotherapy Drugs is a sterile and disposable device. This glove system ismade of synthetic polyisoprene rubber. Gammex® Pl Plus Glove- in-Glove™ System Tested for Use with Chemotherapy Drugs is comprised of a single-use, sterile, white outer glove, which is a disposable, powder-free surgical glove made from synthetic polyisoprene and a single-use, sterile, green underglove which is a disposable, powder-free surgical glove made from syntheticpolyisoprene. The Gammex® Pl PlusGlove-in-Glove™ system Testedfor Use with Chemotherapy Drugs is comprised of the underglove being mechanically inserted into the outer glove prior to packing and sterilization. There is no adhesive present between the two gloves. This results in quick double gloving with only one donning event.
The provided text is a 510(k) Premarket Notification from the FDA regarding the "Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs." This document outlines the device's characteristics, its intended use, and the studies conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document includes a table of non-clinical tests performed on the Gammex® PI Plus Glove-in-Glove™ System.
| Test Title | Purpose of Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D3767-03 | Dimensions | In accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves. | PASS |
| ASTM D3577-19 | Physical Properties | For tensile strength, ultimate elongation and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves per ASTM D3577-19 : Standard Specification for Rubber Surgical Gloves. | PASS |
| ASTM D5151-19 | Freedom from holes | In accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves with AQL requirements of 1.5. | PASS |
| ASTM D6124 | Powder-Free | Applicable acceptance criteria for powder free ≤ 2mg per glove per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves. | PASS |
| ANSI/AAMI/ISO 11137-1:2006 | Sterility | Requirement of 10-6 SAL per ISO 11137-1: Sterilization for health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. | PASS |
| ASTM D6978-05(2019) | Chemotherapy Drug Permeation Test | In accordance with ASTM D6978-05(2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Note: Carmustine (35.0 min) and Thiotepa (67.0 min) have extremely low permeation times, implying these are specific exceptions within the criteria or require special consideration/warnings. | PASS |
| ISO 10993-5 (Outer and Underglove) | ISO in vitro Cytotoxicity Study (Undiluted, 1:2, 1:4, 1:8, 1:16, 1:32, 1:64 dilutions) | Acceptance criteria in accordance with ISO 10993-5: Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity, 2009. (Specifically, for the outer glove: non-cytotoxic at 1:4, 1:8, 1:16, 1:32, and 1:64 dilutions. For the underglove: non-cytotoxic at 1:16, 1:32, and 1:64 dilutions). Intermediate dilutions for both gloves showed varying levels of cytotoxicity. | FAIL (at certain dilutions for both gloves, e.g., undiluted and 1:2 for outer; undiluted, 1:2, 1:4, 1:8 for under) |
| ISO 10993-10:2010 | ISO Skin Irritation Study | Passes Primary Skin Irritation test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization. Not an irritant under study conditions. | PASS |
| ISO 10993-10:2010 | ISO Maximization Sensitization Study | Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization. Not a sensitizer under study conditions. | PASS |
| ISO 10993-11:2017 | ISO Acute Systemic Toxicity Study | Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity. No mortality or evidence of acute systemic toxicity under study conditions. | PASS |
Chemotherapy Drug Permeation Times (Detailed)
| Test Chemotherapy Drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|
| Bleomycin - 15.0 mg/ml | >240 |
| Busulfan - 6.0 mg/ml | >240 |
| Carboplatin - 10 mg/ml | >240 |
| Carmustine - 3.3 mg/ml | 35.0 |
| Cisplatin - 1.0 mg/ml | >240 |
| Cyclophosphamide - 20.0 mg/ml | >240 |
| Cytarabine HCl - 100.0 mg/ml | >240 |
| Dacarbazine - 10.0 mg/ml | >240 |
| Daunorubicin HCl - 5.0 mg/ml | >240 |
| Docetaxel - 10.0 mg/ml | >240 |
| Doxorubicin HCl 2.0 mg/ml | >240 |
| Epirubicin - 2.0 mg/ml | >240 |
| Etoposide - 20.0 mg/ml | >240 |
| Fludarabine - 25 mg/ml | >240 |
| Fluorouracil - 50.0 mg/ml | >240 |
| Gemcitabine - 38.0 mg/ml | >240 |
| Idarubicin - 1.0 mg/ml | >240 |
| Ifosfamide - 50.0 mg/ml | >240 |
| Irinotecan - 20.0 mg/ml | >240 |
| Mechlorethamine HCl - 1.0 mg/ml | >240 |
| Melphalan - 5.0 mg/ml | >240 |
| Methotrexate - 25.0 mg/ml | >240 |
| Mitomycin C - 0.5 mg/ml | >240 |
| Mitoxantrone - 2.0 mg/ml | >240 |
| Oxaliplatin - 2.0 mg/ml | >240 |
| Paclitaxel - 6.0 mg/ml | >240 |
| Rituximab - 10.0 mg/ml | >240 |
| Thiotepa - 10.0 mg/ml | 67.0 |
| Vincristine Sulfate - 1.0 mg/ml | >240 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for individual tests like dimensions, physical properties, freedom from holes, powder-free, sterility, or biocompatibility studies. The general phrasing "Meets ASTM D..." or "Passes..." suggests that the sample sizes typically required by these standards were used.
For the Chemotherapy Drug Permeation Test (ASTM D6978-05), while the results for each drug are provided (Average Breakthrough Detection Time), the document does not specify the number of samples (e.g., gloves or glove specimens) tested for each drug.
The data provenance is prospective in the sense that these are tests conducted specifically for this 510(k) submission to demonstrate the device's performance against established standards. There is no mention of country of origin for the data; it is assumed to be from a testing facility compliant with the mentioned standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The "ground truth" for these tests is defined by the objective measurement methods and acceptance criteria specified in the referenced ASTM, ANSI, and ISO standards. These standards themselves are developed by expert consensus, but specific independent expert adjudication for this particular test set is not mentioned or typically required for this type of device and testing.
4. Adjudication Method for the Test Set:
An explicit adjudication method (like 2+1 or 3+1) is not applicable or mentioned for the non-clinical tests described. The tests are objective measurements against predefined criteria outlined in the consensus standards. The "Pass/Fail" results are determined directly by comparing the test outcomes to these established thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not conducted on the subject device." This type of study focuses on human reader performance, often with or without AI assistance, which is not relevant to the physical and chemical resistance properties of a surgical glove.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
No, a standalone algorithm-only performance study was not done. This device is a physical medical device (surgical glove), not an algorithm or AI software. Therefore, studies evaluating algorithm performance are not relevant.
7. The Type of Ground Truth Used:
The ground truth used for the non-clinical tests is based on consensus standards and laboratory measurements.
- For physical properties, dimensions, freedom from holes, powder residue, and sterility: The ground truth is objective measurement against the specified ASTM and ISO standards' criteria.
- For chemotherapy drug permeation: The ground truth is the measured breakthrough time determined by the ASTM D6978-05 standard.
- For biocompatibility (skin irritation, sensitization, acute systemic toxicity, cytotoxicity): The ground truth is the biological response observed in validated in vitro and in vivo models according to the ISO 10993 series of standards.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product (surgical glove) and does not involve AI or machine learning algorithms that would require a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 26, 2023
Ansell Healthcare Products, LLC Tammy McGriff Manager 2301 Robb Drive Reno, Nevada 89523
Re: K213289
Trade/Device Name: Gammex® PI Plus Glove-in-Glove System™ Tested For Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC, OPJ Dated: May 24, 2023 Received: May 26, 2023
Dear Tammy McGriff:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
{1}------------------------------------------------
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213289
Device Name
Gammex® PI Plus Glove-in-Glove™ System Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove together. Please note that the following drugs have extremely low permeation times: 3.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.
| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|
| Bleomycin - 15.0 mg/ml | >240 |
| Busulfan - 6.0 mg/ml | >240 |
| Carboplatin - 10 mg/ml | >240 |
| Carmustine - 3.3 mg/ml | 35.0 |
| Cisplatin - 1.0 mg/ml | >240 |
| Cyclophosphamide - 20.0 mg/ml | >240 |
| Cytarabine HCl - 100.0 mg/ml | >240 |
| Dacarbazine - 10.0 mg/ml | >240 |
| Daunorubicin HCl - 5.0 mg/ml | >240 |
| Docetaxel - 10.0 mg/ml | >240 |
| Doxorubicin HCl 2.0 mg/ml | >240 |
| Epirubicin - 2.0 mg/ml | >240 |
| Etoposide - 20.0 mg/ml | >240 |
| Fludarabine - 25 mg/ml | >240 |
| Fluorouracil - 50.0 mg/ml | >240 |
| Gemcitabine - 38.0 mg/ml | >240 |
| Idarubicin - 1.0 mg/ml | >240 |
| Ifosfamide - 50.0 mg/ml | >240 |
| Irinotecan - 20.0 mg/ml | >240 |
| Mechlorethamine HCl - 1.0 mg/ml | >240 |
| Melphalan - 5.0 mg/ml | >240 |
| Methotrexate - 25.0 mg/ml | >240 |
| Mitomycin C - 0.5 mg/ml | >240 |
| Mitoxantrone - 2.0 mg/ml | >240 |
| Oxaliplatin - 2.0 mg/ml | >240 |
| Paclitaxel - 6.0 mg/ml | >240 |
| Rituximab - 10.0 mg/ml | >240 |
| Thiotepa - 10.0 mg/ml | 67.0 |
| Vincristine Sulfate - 1.0 mg/ml | >240 |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510KSummary
510(k) Number:
Submitter:
Ansell HealthcareProducts LLC. 2301 Robb Drive Reno, NV 89523
Contact Person(s):
Tammy McGriff Manager, Regulatory Affairs/Quality Assurance Phone: 334-796-9361 Email: tammy.mcgriff@ansell.com
Carson Delaloye Senior Coordinator, Regulatory Affairs Phone: 530-401-8977 Email: carson.delaloye@ansell.com
Date Prepared
May 24, 2023
Name of Device
| Trade Names: | Gammex® PI Plus Glove-in-Glove™ System Tested for Usewith Chemotherapy Drugs |
|---|---|
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Regulation: | 21 CFR 878.4460 |
| Device Class: | I |
| Product Code: | KGO, OPJ, LZC |
| Classification Panel: | General and Plastic Surgery |
Legally Marketed Predicate Device
K190077 – Biogel® PI UltraTouch S Surgical Glove, Biogel® PI Ultra Touch SIndicator Underglove
Legally Marketed Reference Device
K190018 - Gammex® Non-Latex Pl White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
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Device Description
Gammex® Pl Plus Glove-in-Glove™ System tested for use with Chemotherapy Drugs is a sterile and disposable device. This glove system ismade of synthetic polyisoprene rubber. Gammex® Pl Plus Glove- in-Glove™ System Tested for Use with Chemotherapy Drugs is comprised of a single-use, sterile, white outer glove, which is a disposable, powder-free surgical glove made from synthetic polyisoprene and a single-use, sterile, green underglove which is a disposable, powder-free surgical glove made from syntheticpolyisoprene. The Gammex® Pl PlusGlove-in-Glove™ system Testedfor Use with Chemotherapy Drugs is comprised of the underglove being mechanically inserted into the outer glove prior to packing and sterilization. There is no adhesive present between the two gloves. This results in quick double gloving with only one donning event.
Gammex® PI Plus Glove™ System Tested for Use with Chemotherapy Drugs conforms to the following FDA recognized consensus standards: ASTM D3577-19, ASTM D6124-06, ASTM D5151-19, ASTM D412-16, ISO 11137-1:2006, ISO 10993-1:2018, ISO 10993-10:2010, ISO 10993-10:2010, ISO 10993-11:2017, & ASTM D6978-05.
Gammex® PI Plus Glove-in-Glove™ System Tested for Use with Chemotherapy Drugs is available in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0
Indication for Use Statement
Gammex® PI Plus Glove-in-Glove™ System Tested for Use with Chemotherapy Drugs
A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove & outer glove together. Please note that the following drugs have extremely low permeation times: Carmustine: 35.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.
| TEST CHEMOTHERAPY DRUG ANDCONCENTRATION | AVERAGEMINIMUMBREAKTHROUGHDETECTIONTIME(Minutes) |
|---|---|
| Bleomycin (15.0 mg/ml) | >240 |
| Busulfan (6.0 mg/ml) | >240 |
| Carboplatin (10.0 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 35.0 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Cytarabine HCl (100.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Daunorubicin HCl (5.0 mg/ml) | >240 |
| Docetaxel (10.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 |
| Epirubicin (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fludarabine (25.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Gemcitabine (38.0 mg/ml) | >240 |
| Idarubicin (1.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Irinotecan (20.0mg/ml) | >240 |
| Mechlorethamine HCI (1.0 mg/ml) | >240 |
| Melphalan (5.0mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0mg/ml) | >240 |
| Oxaliplatin (2.0 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Rituximab (10.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 67.0 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Tested chemotherapy drugs are as follows:
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Technological Characteristics:
| Predicate Device | Proposed Subject Device | Comparison | |
|---|---|---|---|
| Trade name | Biogel® PI UlltraTouch SSurgical Glove, Biogel® PIUltra Touch S IndicatorGlove | Gammex® PI Plus Glove-in-Glove™ System Tested forUse with ChemotherapyDrugs | Different - NewProduct |
| 510kNumber | K190077 | K213289 | Different -New510(k) |
| Product Owner | Mölnlycke Health Care US,LLC | Ansell Healthcare ProductsLLC | Different - SeparateBusinesses |
| Product Code | KGO | KGO, OPJ, LZC | Different -OPJ,LZC productcodes added for chemo |
| RegulationNumber | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Regulatory Class | I | I | Same |
| RegulationName | Non-powdered Surgeon'sGloves | Non-powdered Surgeon'sglove | Same |
| IndicationsforUse | The Biogel PI UltraTouch SSurgical Glove is a disposabledevice made of polyisoprene, thatis intended to be worn on thehands, usually in a surgicalsetting, to provide a barrieragainst potentially infectiousmaterial and other contaminates.The Biogel PI UltraTouch SIndicator Underglove is adisposable device made ofpolyisoprene, blue in color, that isintended to be worn on thehands, usually in a surgicalsetting, to provide a barrieragainst potentially infectiousmaterial and other contaminants | A powder-free surgeons' glove isintended to be worn by operatingroom personnel toprotect a surgical wound fromcontamination. The glove systemwas tested for use withChemotherapy Drugs as per ASTMD6978-05 Standard Practice forAssessment of Medical Gloves toPermeation by ChemotherapyDrugs. Chemotherapy testing wascarried out on the system as awhole, including both the under-glove & outer-glove together.Please note that the followingdrugs have extremely lowpermeation times: Carmustine:35.0 minutes and Thiotepa: 67.0minutes. Warning: Do not use withCarmustine or Thiotepa. | Different |
| MaterialComposition | Synthetic polyisoprenerubber | Synthetic polyisoprenerubber | Same |
| Coating | Hydrogel Polymer Coating | Polyacrylic Polymer Inner Coating | Different |
| Design | Single use | Single use | Same |
| Powder-free | Powder-free | Same | |
| Hand Specific | Ambidextrous | Different | |
| Beaded cuff | Beaded cuff | Same | |
| Color | Under Glove- BlueOuterGlove-Straw (Natural) | Under Glove—GreenOuter Glove - White | Different - ChangedColor |
| Labeling | Surgeon's Gloves | Surgeon's Gloves | Same |
| Shelf Life | 3 Years | No claimed shelf life | Different |
| Predicate Device | Proposed Subject Device | Comparison | |
| Performancea. Dimensions | Meets ASTM D3577-09 (2015)requirements | Meets ASTM D3577-19requirements | Same |
| b. PhysicalProperties | Meets ASTM D3577-09 (2015)requirements | Meets ASTM D3577-19requirements | Same |
| c. Freedom fromholes | Meets ASTM D3577-09 (2015)AQL Meets CFR 800.20Requirements | Meets ASTM D3577- 19 Gl,AQL 1.5 Requirements | Same |
| d. PowderResidual | Meet applicable definition forpowder free per ASTMD3577-19; ≤ 2mg per glove | Meet applicable definition forpowder free per ASTMD3577-19; ≤ 2mg per glove | Same |
| e. Sterility | Sterile | Sterile | Same |
| BiocompatibilitySkin Irritation | Passes Primary Skin Irritation testper ISO 10993-10, BiologicalEvaluation of medical devices,Part 10: Test for irritation andskin sensitization | Passes Primary Skin Irritation testper ISO 10993-10, BiologicalEvaluation of medical devices,Part 10: Test for irritation andskin sensitization | Same |
| BiocompatibilitySensitization | Passes Dermal Sensitization testper ISO 10993-10, BiologicalEvaluation of medical devices,Part 10: Test for irritation andskin sensitization | Passes Dermal Sensitization testper ISO 10993-10, BiologicalEvaluation of medical devices,Part 10: Test for irritation andskin sensitization | Same |
| BiocompatibilityAcute SystemicToxicity | Passes Acute Systemic ToxicityTest per ISO 10993-11, BiologicalEvaluation of medical devices,Part 11: Test for systemic toxicity | Passes Acute Systemic Toxicity Testper ISO 10993-11, BiologicalEvaluation of medical devices,Part 11: Test for systemic toxicity | Same |
| SterilizationMethod | Gamma Irradiation | Gamma Irradiation | Same |
| SterilizationInformation | Meets ANSI/AAMI/ISO 11137-1:2006requirement of 10-6 SAL. | Meets ANSI/AAMI/ISO 11137-1:2006requirement of 10-6 SAL. | Same |
| Prescription orOver thecounter | Over the Counter | Over the Counter | Same |
Technological Characteristics Comparison Table for Predicate Device
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Itemized List of Differences Between Predicate and Proposed:
- Trade Name
- The difference is that the trade names are different due to the gloves being separate styles from sperate O owners. There is no impact on the safety or effectiveness with the changing of device names.
- 510k Number
- There are different 510k numbers because they are different owners. There is no impact o on the safety or effectiveness with the predicate and proposed having different 510ks.
- Product Owner
- o There are different product owners for the proposed and predicate devices. There is no impact on safety or effectiveness with the predicate as this device has already been FDA cleared.
- FDA Product Code
- The predicate device does not have chemotherapy testing so there is no OPJ or LZC product code. O
- Indications for Use
- o There are different indications for use listed as the predicate device does not have chemotherapy data or indications for such use.
- Coating
- The sum total of all performance safety and efficacy testing presented indicates that the proposed device is as о safe and effective as the predicate and reference device.
- Design
- O The predicate device is listed as a hand specific glove, while the proposed is ambidextrous. There is no change to safety or efficacy as the gloves have different donning methods.
- Color
- The predicate device is two gloves, the outer being straw colored and the under glove being blue. O
- The proposed device is two gloves, the outer being white and the under glove being green. O
- O The sum total of all performance safety and efficacy testing presented indicates that the proposed device is as safe and effective as the predicate and reference device.
- Shelf Life ●
- O There is no claimed shelf life for the proposed device.
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Technological Characteristics:
| Reference Device | Proposed Subject Device | Comparison | |
|---|---|---|---|
| Trade name | Gammex® Non-Latex PIWhite Polyisoprene SurgicalGloves Tested for Use withChemotherapy Drugs | Gammex® PI Plus Glove-in-Glove™ System Tested forUse with ChemotherapyDrugs | Different - NewProduct |
| 510kNumber | K190018 | K213289 | Different - New510(k) |
| Product Owner | Ansell Healthcare ProductsLLC | Ansell Healthcare ProductsLLC | Same |
| Product Code | KGO, OPJ | KGO, OPJ, LZC | Different -LZC added |
| RegulationNumber | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Regulatory Class | Same | ||
| RegulationName | Non-powdered Surgeon'sGloves | Non-powdered Surgeon'sGloves | Same |
| IndicationsforUse | Gammex Non Latex PI WhiteSurgical Gloves Tested for Usewith Chemotherapy Drugs areintended to be worn byoperating room personnel toprotect a surgical wound fromcontamination. These gloveswere tested for use withChemotherapy Drugs as perASTM D6978-05 StandardPractices for Assessment ofMedical Gloves to Permeationby Chemotherapy Drugs. | A powder-free surgeons' glove isintended to be worn by operatingroom personnel toprotect a surgical wound fromcontamination. The glovesystem was tested for use withChemotherapy Drugs as perASTM D6978-05 StandardPractice for Assessment ofMedical Gloves to Permeationby Chemotherapy Drugs.Chemotherapy testing wascarried out on the system as awhole, including both theunder-glove & outer-glovetogether. Please note that thefollowing drugs have extremelylow permeation times:Carmustine: 35.0 minutes andThiotepa: 67.0 minutes.Warning: Do not use withCarmustine or Thiotepa. | Different |
| MaterialComposition | Synthetic polyisoprenerubber | Synthetic polyisoprenerubber | Same |
| Coating | Polyacrylic Polymer InnerCoating | Polyacrylic Polymer InnerCoating | Same |
| Design | Single use | Single use | Same |
| Powder-free | Powder-free | Same | |
| Hand Specific | Ambidextrous | Different | |
| Beaded cuff | Beaded cuff | Same | |
| Color | White | Under Glove – GreenOuter Glove - White | Different - ChangedColor |
| Labeling | Surgeon's Gloves | Surgeon's Gloves | Same |
| Shelf Life | 2 Years | No claimed shelf life | Different |
| Reference Device | Proposed Subject Device | Comparison | |
| Performancea. Dimensions | Meets ASTM D3577-09 (2015)requirements | Meets ASTM D3577-19requirements | Same |
| b. PhysicalProperties | Meets ASTM D3577-09 (2015)requirements | Meets ASTM D3577-19requirements | Same |
| c. Freedom fromholes | Meets ASTM D3577- 19 GI, AQL1.5Requirements | Meets ASTM D3577- 19 GI, AQL1.5Requirements | Same |
| d. PowderResidual | Meet applicable definition forpowder free per ASTMD3577-19; $\le$ 2mg per glove | Meet applicable definition forpowder free per ASTMD3577-19; $\le$ 2mg per glove | Same |
| e. Sterility | Sterile | Sterile | Same |
| BiocompatibilitySkin Irritation | Passes Primary Skin Irritation testper ISO 10993-10, BiologicalEvaluation of medical devices, Part10: Test for irritation and skinsensitization | Passes Primary Skin Irritation testper ISO 10993-10, BiologicalEvaluation of medical devices,Part 10: Test for irritation andskin sensitization | Same |
| BiocompatibilitySensitization | Passes Dermal Sensitization testper ISO 10993-10, BiologicalEvaluation of medical devices,Part 10: Test for irritation andskin sensitization | Passes Dermal Sensitization testper ISO 10993-10, BiologicalEvaluation of medical devices,Part 10: Test for irritation andskin sensitization | Same |
| BiocompatibilityAcute SystemicToxicity | Passes Acute Systemic ToxicityTest per ISO 10993-11, BiologicalEvaluation of medical devices,Part 11: Test for systemic toxicity | Passes Acute Systemic Toxicity Testper ISO 10993-11, BiologicalEvaluation of medical devices,Part 11: Test for systemic toxicity | Same |
| SterilizationMethod | Gamma Irradiation | Gamma Irradiation | Same |
| SterilizationInformation | Meets ANSI/AAMI/ISO 11137-1:2006requirement of 10-6 SAL. | Meets ANSI/AAMI/ISO 11137-1:2006requirement of 10-6 SAL. | Same |
| Prescription orOver thecounter | Over the Counter | Over the Counter | Same |
Technological Characteristics Comparison Table for Reference Device
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ltemized List of Differences Between Reference and Proposed:
- . Trade Name
- o The difference is that the trade names are different due to the gloves being separate styles. There is no impact on the safety or effectiveness with the changing of device names.
- . 510k Number
- o There are different 510k numbers because they are different devices. There is no impact on the safety or effectiveness with the reference and proposed having different 510ks.
- . Indications for Use
- o There are different indications for use listed as the predicate device does not have chemotherapy data or indications for such use.
- . Design
- O The predicate device is listed as a hand specific glove, while the proposed is ambidextrous. There is no change to safety or efficacy as the gloves have different donning methods.
- . Color
- The sum total of all performance safety and efficacy testing presented indicates that the proposed device is as O safe and effective as the predicate and reference device.
- . Shelf Life
- o There is no claimed shelf life for the proposed device.
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| Predicate Device | Proposed Subject Device | Comparison | |
|---|---|---|---|
| Trade Name | Biogel® PI UlltraTouch S SurgicalGlove, Biogel® PI Ultra Touch SIndicator Glove | Gammex® PI Plus Glove-in-Glove™ System Tested forUse with ChemotherapyDrugs | DifferentDevices |
| ChemotherapyClaim | Tested chemotherapydrugs/concentration & AverageMinimum BreakthroughDetection Time (Minutes) are asfollows | A powder-free surgeons' glove isintended to be worn byoperating room personnel toprotect a surgical wound fromcontamination. The glove wastested for use withChemotherapy Drugs as perASTM D6978-05 StandardPractice for Assessment ofMedical Gloves to Permeation byChemotherapy Drugs.Chemotherapy testing wascarried out on the system as awhole, including both the under-glove & outer glove together.Please note that the followingdrugs have extremely lowpermeationtimes: Carmustine:35.0 minutes and Thiotepa: 67.0minutes. Warning: Do not usewith Carmustine or Thiotepa.Tested chemotherapydrugs/concentration& Average MinimumBreakthroughDetection Time(Minutes) are asfollows: | Different |
| Not Available for Device | Busulfan (6.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Carmustine (3.3 mg/ml)35.0 | Different | |
| Not Available for Device | Cisplatin (1.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Cyclophosphamide (20.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Cytarabine (100.0 mg/ml)>240 min. | Different | |
| Predicate Device | Proposed Subject Device | Comparison | |
| Not Available for Device | Dacarbazine (10.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Daunorubicin HCl (5.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Docetaxel (10.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Doxorubicin HCl (2.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Etoposide (20.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Fludarabine (25.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Fluorouracil (50.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Gemcitabine (38.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Idarubicin (1.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Ifosfamide (50.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Irinotecan (20.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Mechlorethamine HCl (1.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Melphalan (5.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Methotrexate (25.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Mitomycin C (0.5 mg/ml)>240 min. | Different | |
| Not Available for Device | Mitoxantrone (2.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Oxaliplatin (2.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Paclitaxel (6.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Rituximab (10.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Thiotepa (10.0 mg/ml)67.0 | Different | |
| Not Available for Device | Vincristine Sulfate (1.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Bleomycin (15.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Carboplatin (10.0 mg/ml)>240 min. | Different | |
| Not Available for Device | Epirubicin (2.0 mg/ml)>240 min. | Different | |
| Reference Device | Proposed Subject Device | Comparison | |
| Trade Name | Gammex® Non-LatexPolyisoprene White SurgicalGloves Tested for Use withChemotherapy Drugs. | Gammex® PI Plus Glove-in-Glove™ System Tested forUse with ChemotherapyDrugs | DifferentDevices |
| Chemotherapy Claim | These gloves are intended to be wornby operating personnel toprotect a surgical wound fromcontamination.These gloves were tested for usewithChemotherapy Drugs as per ASTMD6978-05 Standard Practice forAssessment of Medical Gloves toPermeation by ChemotherapyDrugs.Tested chemotherapydrugs/concentration &Average MinimumBreakthrough Detection Time(Minutes) are as follows | A powder-free surgeons' gloveis intended to be worn byoperating room personnel toprotect a surgical wound fromcontamination. The glove wastested for use withChemotherapy Drugs as perASTM D6978-05 StandardPractice for Assessment ofMedical Gloves to Permeationby Chemotherapy Drugs.Chemotherapy testing wascarried out on the system as awhole, including both theunder-glove & outer glove together.Please note that the followingdrugs have extremely lowpermeationtimes: Carmustine:35.0 minutes and Thiotepa: 67.0minutes. Warning: Do not usewith Carmustine or Thiotepa.Tested chemotherapydrugs/concentration & AverageMinimumBreakthroughDetection Time(Minutes) are asfollows: | |
| Busulfan (6.0 mg/ml)>240 min. | Busulfan (6.0 mg/ml)>240 min. | Same | |
| Carmustine (3.3 mg/ml)10.2 | Carmustine (3.3 mg/ml)35.0 | Different | |
| Cisplatin (1.0 mg/ml)>240 min. | Cisplatin (1.0 mg/ml)>240 min. | Same | |
| Cyclophosphamide (20.0 mg/ml)>240 min. | Cyclophosphamide (20.0 mg/ml)>240 min. | Same | |
| Cytarabine (100.0 mg/ml)>240 min. | Cytarabine (100.0 mg/ml)>240 min. | Same | |
| Dacarbazine (10.0 mg/ml)>240 min. | Dacarbazine (10.0 mg/ml)>240 min. | Same | |
| Reference Device | Proposed Subject Device | Comparison | |
| Daunorubicin HCl (5.0 mg/ml)>240 min. | Daunorubicin HCl (5.0 mg/ml)>240 min. | Same | |
| Docetaxel (10.0 mg/ml)>240 min. | Docetaxel (10.0 mg/ml)>240 min. | Same | |
| Doxorubicin HCl (2.0 mg/ml)>240 min. | Doxorubicin HCl (2.0 mg/ml)>240 min. | Same | |
| Etoposide (20.0 mg/ml)>240 min. | Etoposide (20.0 mg/ml)>240 min. | Same | |
| Fludarabine (25.0 mg/ml)>240 min. | Fludarabine (25.0 mg/ml)>240 min. | Same | |
| Fluorouracil (50.0 mg/ml)>240 min. | Fluorouracil (50.0 mg/ml)>240 min. | Same | |
| Gemcitabine (38.0 mg/ml)>240 min. | Gemcitabine (38.0 mg/ml)>240 min. | Same | |
| Idarubicin (1.0 mg/ml)>240 min. | Idarubicin (1.0 mg/ml)>240 min. | Same | |
| Ifosfamide(50.0 mg/ml)>240 min. | Ifosfamide(50.0 mg/ml)>240 min. | Same | |
| Irinotecan (20.0 mg/ml)>240 min. | Irinotecan (20.0 mg/ml)>240 min. | Same | |
| Mechlorethamine HCl (1.0 mg/ml)>240 min. | Mechlorethamine HCl (1.0 mg/ml)>240 min. | Same | |
| Melphalan (5.0 mg/ml)>240 min. | Melphalan (5.0 mg/ml)>240 min. | Same | |
| Methotrexate (25.0 mg/ml)>240 min. | Methotrexate (25.0 mg/ml)>240 min. | Same | |
| Mitomycin C (0.5 mg/ml)>240 min. | Mitomycin C (0.5 mg/ml)>240 min. | Same | |
| Mitoxantrone (2.0 mg/ml)>240 min. | Mitoxantrone (2.0 mg/ml)>240 min. | Same | |
| Oxaliplatin (2.0 mg/ml)>240 min. | Oxaliplatin (2.0 mg/ml)>240 min. | Same | |
| Paclitaxel (6.0 mg/ml)>240 min. | Paclitaxel (6.0 mg/ml)>240 min. | Same | |
| Reference Device | Proposed Subject Device | Comparison | |
| Rituximab(10.0 mg/ml)>240 min. | Rituximab(10.0 mg/ml)>240 min. | Same | |
| Thiotepa (10.0 mg/ml)11.5 | Thiotepa (10.0 mg/ml)67.0 | Different | |
| Vincristine Sulfate(1.0 mg/ml)>240 min. | Vincristine Sulfate (1.0 mg/ml)>240 min. | Same | |
| Bleomycin(15.0 mg/ml)>240 min. | Bleomycin(15.0 mg/ml)>240 min. | Same | |
| Carboplatin(10.0 mg/ml)>240 min. | Carboplatin(10.0 mg/ml)>240 min. | Same | |
| Epirubicin (2.0 mg/ml)>240 min. | Epirubicin (2.0 mg/ml)>240 min. | Same |
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ltemized List of Chemotherapy Differences Between Predicate and Proposed:
- The predicate device was not tested for use with chemotherapy drugs. The safety and efficacy of the . proposed device with respect to chemotherapy drugs is addressed through the performance testing and labeling of the device.
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{17}------------------------------------------------
Itemized List of Chemotherapy Differences Between Reference and Proposed:
- The proposed device has a longer breakthrough time for Carmustine. This show safety and efficacy as the reference . device has already been cleared with lower breakthrough times.
- . The proposed device has a longer breakthrough time for This show safety and efficacy as the reference device has already been cleared with lower breakthrough times.
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The subject device meets the applicable requirements for surgeons's gloves with regards to dimensions and sizes, physical properties, freedom from holes, and powder residues as found in the following standards: ASTM D3577, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization, and acute systemic toxicity, in accord with the ISO 10993 series of standards.
Non-Clinical Testing
Gammex® PI Plus Glove™ System Tested for Use with Chemotherapy Drugs has the following technological characteristics as compared to ASTM or equivalent standards:
| Results | Title of Test | Purpose of Test | Acceptance Criteria |
|---|---|---|---|
| PASS | ASTMD3767-03 | Dimensions | Acceptance criteria in accordance with ASTM D3577-19: StandardSpecification for Rubber Surgical Gloves |
| PASS | ASTMD3577-19 | Physical Properties | Acceptance criteria for tensile strength, ultimate elongation andstress at 500% elongation before and after accelerated aging forsynthetic surgical gloves per ASTM D3577-19 : Standard Specificationfor Rubber Surgical Gloves |
| PASS | ASTMD5151-19 | Freedom fromholes | Acceptance criteria in accordance with ASTM D3577-19: StandardSpecification for Rubber Surgical Gloves with AQL requirements of 1.5 |
| PASS | ASTMD6124 | Powder-Free | Meets applicable acceptance criteria for powder free ≤ 2mg per gloveper ASTM D3577-19: Standard Specification for Rubber Surgical Gloves |
| PASS | ANSI/AAMI/ISO 11137-1:2006 | Sterility | Meets acceptancecriteria requirement of 10-6 SAL per ISO 11137-1:Sterilization for health care products – Radiation – Part 1: Requirementsfor development, validation and routine control of a sterilization processfor medical devices |
| PASS | ASTMD6978-05(2019) | ChemotherapyDrugPermeationTest: | Acceptance Criteria in accordance with ASTM D6978-05(2019):Standard Practice for Assessment of Resistance of Medical Gloves toPermeation by Chemotherapy Drugs.*Please note that the following drugs have extremely lowpermeation times: Carmustine (35.0 min) and Thiotepa (67.0 min) |
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| ISO 10993-5 | Biocompatibility: | Gammex®Non-Latex PI SurgicalGlove (Outerglove) | Gammex®Non-Latex PlUnderglove (Underglove) | |
|---|---|---|---|---|
| FAIL | ISO 10993-5 | ISO in vitroCytotoxicityStudy | Surfaces at undiluted and at thedilution of 1:2 was found to becytotoxic (grade 4) to L-929 cellspost 48 hour and non-cytotoxic at1:4 dilution with grade 2 and withgrade 0 at 1:8, :16, 1:32 and 1;64dilutions. Acceptance criteria inaccordance with ISO 10993-5:Biological Evaluation of MedicalDevices, Part 5: Tests for In VitroCytotoxicity, 2009. | Dilutions of 1:16, 1:32, and 1:64were found to be non-cytotoxic(grade 0). Dilution 1:8 showedmoderate cytotoxicity (grade 3).Undiluted, 1:2, and 1:4 dilutionsshowed severe positivecytotoxicity (grade 4). Acceptancecriteria in accordance with ISO10993-5: Biological Evaluation ofMedical Devices, Part 5: Tests for InVitro Cytotoxicity, 2009. |
| PASS | ISO 10993-10:2010 | ISO SkinIrritationStudy | Passes Primary Skin Irritation test per ISO 10993-10, BiologicalEvaluation of medical devices, Part 10: Test for irritation and skinsensitization. Under the conditions of the study, not an irritant. | |
| PASS | ISO 10993-10:2010 | ISOMaximizationSensitizationStudy | Passes Dermal Sensitization test per ISO 10993-10, BiologicalEvaluation of medical devices, Part 10: Test for irritation and skinsensitization. Under the conditions of the study, not a sensitizer | |
| PASS | ISO 10993-11:2017 | ISOAcute SystemicToxicity Study –ISO10993-11:2017 | Passes Acute Systemic Toxicity Test per ISO 10993-11, BiologicalEvaluation of medical devices, Part 11: Test for systemic toxicity.Under the conditions of the study, there was no mortality orevidence of acute systemic toxicity |
Clinical Studies
A clinical study was not conducted on the subject device.
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).